K251105
- 510(k) number
- K251105
- Device name
- Tetra (TM-20); Tetra (TM-50)
- Applicant
- Emed Technologies Corporation CA · US
- Product code
- PKP — Immunoglobulin G (Igg) Infusion System
- Decision date
- 2025-12-22
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251105.pdf
Official FDA record: K251105
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.